“A Clinical study on the efficacy ofMinimal Invasive Kshara-Sutra Technique (MIKST)in the management of Bhagandara w.s.r. to High anal fistulaâ€
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To evaluate the efficacy of Minimal Invasive Kshara Sutra Technique (MIKST) in the management of Bhagandara (High anal fistula)
研究概览
简要总结
In Ayurveda, Bhagandara has been mentioned as one among the Ashtomahagada (eight major diseases) because of its callous attitude. The references of Bhagandara can be traced back to Garuda Purana. Detailed description of Bhagandara is mentioned in Susruta Samhita in Chikitsa Sthana 8thchapter.
Bhagandara can be compared to Fistula-in-ano in modern science on the basis of similarities in the symptomatology mentioned in Ayurveda and Modern text books. Bhagandara (Fistula-in-ano) is one of the oldest diseases known to the Medical Science. Fistula-in-ano is a common ano-rectal condition prevalent in the population worldwide and its prevalence is second after hemorrhoids. Hippocrates made reference to surgical Therapy for Fistula-in-ano. In 1376, the English Surgeon John Arderne (1307-1390 AD) wrote treatises of Fistula-in-ano, Hemorrhoids and clysters which described Fistulotomy and use of Seton in Fistula-in-ano. In the 19 century Goodsall and Miles, Milligan and Morgan, Thompson, Lockhart Mummery and Parks made substantial contribution in description and treatment of Fistula-in-ano.
Acharya Susruta has mentioned that all types of Bhagandara are difficult to treat3. In modern Surgery also it is known for its callous nature towards cure and recurrence rate. According to a recent survey conducted by Sainiop4 on the prevalence rate of Fistula-in-ano in a London based hospital is 8.6 cases per 1,00,000 population. In men: 12.3 cases per 1,00,000 population and in women: 5.6 cases per 10,000 population, Male:female = 1.8:1, Mean age of patient: 38.3 years. 10% of all indoor patients and 4% of all outdoor patients were reported to be suffering from this disease. A similar study conducted in India has reported that Fistula-in-ano constitutes about 15-16 % of all ano-rectal disorders. It is being managed by specialized Proctologists and Surgeons. But inspite of all the possible efforts, the recurrence rate is very high i.e. 20 to 30% which is a big challenge before the surgeon’s community.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Open Label
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male or female between age 20 to 60 years and willing to give their written informed consent.
- •No major systemic disease involved.
- •Patients who have signs and symptoms of Bhagandara /Fistula-in-ano of length more than 4cm from anal canal.
- •Patients who have signs and symptoms of High anal fistula and Trans-sphincteric fistula.
- •Recurrent High anal fistula and Trans-sphincteric fistula.
排除标准
- •Male or female less than 20 years and greater than 60 years of age.
- •Patient with known hypersensitivity to any of the components of the formulation.
- •Fistula of length less than 4 cm from anal canal.
- •Supra-sphincteric and Extra-sphincteric fistula.
- •Multiple fistulas.
结局指标
主要结局
To evaluate the efficacy of Minimal Invasive Kshara Sutra Technique (MIKST) in the management of Bhagandara (High anal fistula)
时间窗: 3 month
次要结局
- To evaluate the better surgical methods in fistula in ano.(3 months)